RAC Post-Market Surveillance 3

Question 1

Under EU MDR 2017/745, what is a 'Field Safety Corrective Action' (FSCA)?

Accepted Answer

An action taken to reduce risk of death or serious deterioration in health associated with a device already on the market

Answer

A scheduled preventive maintenance activity by the manufacturer

Answer

A recall initiated solely for commercial reasons

Answer

An internal audit of the manufacturing process

Question 2

Which metric is MOST useful for quantifying the real-world safety signal in post-market surveillance data?

Accepted Answer

Complaint rate per units distributed

Answer

Gross revenue per product line

Answer

Number of social media mentions

Answer

Total units manufactured per quarter

Question 3

Under 21 CFR Part 803, a device manufacturer must report a device-related death within how many calendar days of becoming aware?

Accepted Answer

30 days

Answer

5 days

Answer

15 days

Answer

45 days

Question 4

Which of the following is a proactive PMS data source, as distinguished from a reactive one?

Accepted Answer

Literature surveillance reviewing published clinical studies

Answer

Customer complaint records received after a device failure

Answer

MDRs filed following a patient injury

Answer

Regulatory authority safety alerts issued after incidents

Question 5

A company receives a complaint that a sterile device's packaging was found breached upon receipt. What PMS action is MOST critical to initiate first?

Accepted Answer

Assess the complaint for MDR reportability and initiate a CAPA investigation

Answer

Send a replacement device immediately and close the complaint

Answer

Instruct the customer to use the device anyway if it appears undamaged

Answer

Wait for additional similar complaints before taking action

Question 6

What distinguishes a Post-Market Surveillance Report (PMSR) from a Periodic Safety Update Report (PSUR) under EU MDR?

Accepted Answer

PMSRs are for Class I devices only; PSURs are required for Class IIa, IIb, and III

Answer

PSURs are for Class I devices; PMSRs apply to higher-risk classes

Answer

PMSRs and PSURs are interchangeable terms under EU MDR

Answer

Both are required for all device classes regardless of risk

Question 7

In the context of PMS complaint handling, what does 'MDR decisioning' require the manufacturer to document?

Accepted Answer

The rationale for why a complaint does or does not meet MDR reporting criteria

Answer

The customer's satisfaction score after complaint resolution

Answer

Marketing strategy changes resulting from the complaint

Answer

The number of social media reposts of the complaint